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RapidKey COVID-19 Antigen Self Test (1)
EUDAMEDClass IVD General (EU MDR)
Ref 301111
Identity
- Trade Name
- RapidKey COVID-19 Antigen Self Test (1) EUDAMED
- Device Name
- RapidKey COVID-19 Antigen Self Test (1) EUDAMED
- Model / Reference
- 301111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013959512 EUDAMED
- Basic UDI-DI
- B-08885013959512 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
RapidKey COVID-19 Antigen Self Test (1) by Vela Operations Singapore Pte. Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08885013959512 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- EUDAMED SRN
- SG-MF-000025684
- Authorised Representative
- Vela Diagnostics Germany GmbH DE-AR-000016088
Sources (1)
- EUDAMED 38117b93-c783-4dcc-bd26-73c8667712ed 61 fields · synced Jul 17, 2026